New devices that promise to make you smarter, more energized, or enhanced in some other way continue to appear on the market. The foc.us device for enhanced gaming and Thync device for energy and relaxation are amongst a number of consumer devices that use electrical stimulation to change the activity of neurons in the brain.
In 2004, Martha Farah and colleagues predicted, “Regulatory agencies might find their responsibilities expanding into considerations of 'lifestyle' benefits and the definition of acceptable risk in exchange for such benefits.” Twelve years on, and this is precisely what is starting to happen in the European regulatory context, and further afield. Devices sold for enhancement present new challenges for conceptualizing, measuring and weighing risks and benefits. Unlike the clear benefits conferred by traditional medical devices, such as reduced pain or alleviation of depression, it is hard to decide how beneficial enhanced gaming or improvements to ‘healthy’ memory abilities are, if at all. It is even more difficult to determine whether these benefits are worth the (mostly unknown) risks associated with regularly sending electricity through your brain.
Since our Oxford Martin Policy paper, Mind Machines, on the regulation of brain stimulation devices was launched in April 2014, I have been addressing precisely these regulatory questions in collaboration with individuals at the Medicines and Healthcare products Regulatory Agency and the European Commission’s Working Group on New and Emerging Technologies. Whilst the precise form that new regulation will take is yet to be formally settled, I have continued to advise regulatory professionals on the possibilities for amending the European Medical Devices Directive to bring consumer brain stimulation, and other enhancement devices, within existing frameworks. Following the recommendations made in our Oxford Martin School policy paper, it is likely that devices intended to modify neuronal activity by passing electrical currents or magnetic fields through the skull will appear in Annex XV of the revised Medical Devices Directive, which is dedicated to those devices without a medical purpose that regulators nonetheless think should be made to conform to particular standards.
In determining whether a particular device can be placed on the market, the current regulatory framework proceeds on the assumption that benefits can easily be quantified and weighed against risks. Whilst it is certainly the case that improvements to cognitive capacities that go beyond traditional treatments can be measured – i.e. we can obtain data on improved working memory scores, for example – it is less clear how valuable these improvements are and, correspondingly, whether their attainment is worth the risks. Given that people’s ideas about which enhancements will be beneficial to them will plausibly show much more variation than their ideas relating to standard treatment effects, there is an argument for placing this assessment more squarely in the hands of the consumers who will be assuming the risks. However, this doesn’t mean that anything goes when it comes to putting devices that change people’s brains onto the market. Consumers need detailed information, and need to be protected from unnecessary risk and unsubstantiated claims. Working out how to operationalize these principles to draft new regulatory instruments is a complicated task, and one that requires neuroscientists, ethicists and regulators to work together.
My most recent engagement with the regulatory community took me to the head offices of TORPA, the professional membership organization for individuals who work in healthcare regulatory affairs across Europe. Here, in collaboration with Mika Reinikainan (European Commission’s WG on New & Emerging Technology), I addressed members of the organization in a seminar on the 8 March.
The purpose of the seminar was to further raise awareness of the need to bring brain stimulation devices sold for enhancement purposes within medical devices regulation, and to engage regulators directly in discussion about how the risks and benefits should be assessed within a regulatory framework not currently designed for non-medical consumer products.
Our role in helping to shape the regulations governing devices sold for enhancement continues.
- A write up of the seminar and ensuing discussion can be found here.